Tissue fixation delivery apparatus

ABSTRACT

A device for deploying a tissue fixation apparatus of the type including first and second tissue anchors coupled together by an adjustable suture assembly. The device comprises a handle mechanism and a needle cartridge assembly releasably coupled to the handle mechanism. The needle cartridge assembly includes a needle cannula with a side opening through which a tissue anchor can be loaded into an internal chamber of the needle cannula. A push rod is disposed in the needle cannula and is operable between an extended position in which the push rod prevents the tissue anchor from entering the chamber through the side opening, and a retracted configuration in which the tissue anchor can be pushed into the chamber under the action of a resilient band positioned over the side opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/024,259 filed Sep. 11, 2013 which claims the benefit under 35 U.S.C.§119(e) of U.S. Provisional Patent Application Ser. No. 61/704,009 filedSep. 21, 2012, both of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to medical devices and methods for tissueanchoring and fixation. More specifically, the invention relates todevices and methods for deploying tissue anchors into soft tissues ofthe body.

BACKGROUND

Various medical procedures benefit from the use of tissue fixationdevices for repairing damaged tissues and/or for securing other devicesto the patient. Exemplary tissue fixation devices can include one ormore tissue and/or bone anchors coupled to one or more suture elements.The particular configuration of the anchor/suture constructs can varyfrom procedure to procedure. There is a continuing need for improveddevices and methods for deploying such tissue fixation devices in anefficient manner.

SUMMARY

In Example 1, the present invention is a device for deploying a tissuefixation apparatus of the type including first and second tissue anchorscoupled together by an adjustable suture assembly. The device comprisesa handle mechanism and a needle cartridge assembly releasably coupled tothe handle mechanism. The handle mechanism includes a handle body, atubular shaft, a plunger, and a handle push rod. The handle body has aproximal end and a distal end and an internal cavity disposedtherebetween. The tubular shaft extends distally from the handle bodyand having a distal end. The plunger is slidably and rotatably coupledto the body and has a proximal end and a distal end, the proximal endpositioned external to and proximal to the handle body, the distal endpositioned within the internal cavity of the body. The handle push rodextends distally from the plunger and is slidably and rotatably disposedwithin the tubular shaft, and includes a distal mating feature. Theneedle cartridge assembly includes a needle cannula, a tubular sleeve, acartridge push rod, and a resilient band. The needle cannula has anouter wall defining a proximal portion, an opposite sharpened distal tiphaving a distal opening, an internal chamber extending from the proximalportion through the distal opening, and a needle side opening throughthe outer wall. The tubular sleeve is fixedly disposed about a portionof the needle cannula and has a proximal end and a distal end, theproximal end of the tubular sleeve configured to mate with the distalend of the tubular shaft of the handle mechanism for coupling the handlemechanism and the needle cartridge assembly. The tubular sleeve furtherincludes a sleeve side opening radially and axially aligned with theneedle side opening. The cartridge push rod is slidably and rotatablydisposed within the chamber of the needle cannula and includes aproximal mating feature configured to engage the distal mating featureof the handle push rod. The resilient band is disposed about disposedthe tubular sleeve within the groove and over the side opening. Prior todeployment the first tissue anchor is disposed within the internalchamber of the needle cannula and the second tissue anchor is disposedexternal to the internal chamber within the side opening in the sleeve,and wherein the plunger, the handle push rod and the cartridge push rodare positioned such that the cartridge push rod operates to prevent thesecond tissue anchor from entering the internal chamber while theresilient band operates to urge the second tissue anchor toward theinternal chamber.

In Example 2, the device of Example 1, wherein the plunger and thehandle and cartridge push rods are configured to operate between atleast one extended position and at least one retracted position, whereinin the at least one extended position the cartridge push rod is locatedso as to eject the first tissue anchor from the chamber through thedistal opening of the needle cannula while preventing the second tissueanchor from entering the internal chamber, and wherein in the at leastone retracted position the cartridge push rod is positioned proximal tothe side opening in the sleeve so as to allow the second tissue anchorto be urged into the internal chamber through the needle side opening bythe resilient band.

In Example 3, the device of Example 2, wherein the plunger and thehandle and cartridge push rods are further configured to be operable toeject the second tissue anchor from the internal chamber through thedistal opening of the needle cannula.

In Example 4, the device of any of Examples 1-3, wherein the proximalend of the tubular sleeve includes a proximal opening configured toreceive the distal end of the tubular shaft of the handle mechanism soas to couple the handle mechanism to the needle cartridge assembly.

In Example 5, the device of Example 4, wherein the distal end of thetubular shaft and the proximal opening of the tubular sleeve are sizedto form an interference fit therebetween to couple the handle mechanismto the needle cartridge assembly.

In Example 6, the device of any of Examples 1-5, wherein the distal endof the tubular shaft includes an alignment pin extending radiallyoutward therefrom, and wherein the proximal end of the tubular sleeveincludes a notch sized to receive the alignment pin to radially alignthe handle mechanism and the needle cartridge.

In Example 7, the device of any of Examples 1-6, wherein the handlemechanism and the needle cartridge assembly are releasably couple to oneanother in such a way that, upon relative separation thereof, the distalmating feature of the handle push rod and the proximal mating feature ofthe cartridge push rod are configured to disengage one another.

In Example 8, the device of any of Examples 1-7, wherein the plunger hasan intermediate section including an outer surface and a groovearrangement therein, and wherein the handle mechanism further includes aguide pin extending radially inward, the guide pin being spring biasedtoward the plunger so as to extend partially within the groovearrangement to regulate longitudinal and rotational movement of theplunger relative to the handle body.

In Example 9, the device of any of Examples 1-8, wherein prior tocomplete deployment of the tissue fixation apparatus a portion of thesuture assembly is releasably coupled to the handle mechanism.

In Example 10, the device of any of Examples 1-9, wherein the tubularsleeve and the needle cannula each further include a slot extending fromthe distal end thereof to the side opening thereof, the tubular sleeveslot being radially aligned with the slot in the needle cannula.

In Example 11, the device of Example 10, wherein the slots of thetubular sleeve and the needle cannula are sized to receive at least aportion of the adjustable suture assembly of the tissue fixationapparatus.

In Example 12, a method of deploying a tissue fixation apparatus of thetype including first and second tissue anchors coupled together by anadjustable suture assembly, the tissue fixation apparatus beingpre-loaded onto a delivery tool with the first tissue anchor disposedwithin an interior chamber of a needle cannula of the delivery tool. Themethod comprises inserting a sharpened distal tip of the needle cannulainto target tissue at a first location, and then advancing a push roddistally within the needle cannula to eject the first tissue anchor fromthe needle cannula within the target tissue at the first location. Themethod further comprises then withdrawing the needle cannula from thefirst location and inserting the sharpened distal tip into the targettissue at a second location, and withdrawing the push rod with respectto the needle cannula to allow the second tissue anchor to be pushedinto the interior chamber of the needle cannula under the operation of aresilient band disposed about the needle cannula and the second tissueanchor. The method further comprises next advancing the push roddistally within the needle cannula to eject the second tissue anchorfrom the needle cannula within the target tissue at the second location,and then withdrawing the needle cannula from the tissue and tighteningthe tissue fixation apparatus.

In Example 13, the method of Example 12, wherein the delivery toolincludes a handle mechanism and a needle cartridge assembly includingthe needle cannula, and wherein the tissue fixation apparatus ispreloaded onto the needle cartridge assembly, and wherein the methodfurther comprises coupling the handle mechanism and the needle cartridgeassembly together prior to inserting the sharpened distal tip of theneedle cannula into the target tissue.

In Example 14, the method of any of Examples 12-13, further comprisingdecoupling the needle cartridge assembly and the handle mechanism afterwithdrawing the needle cannula from the target tissue.

In Example 15, the method of any of Examples 12-14, wherein coupling thehandle mechanism and the needle cartridge assembly together includesinserting a tubular shaft of the handle mechanism into a proximalopening of the needle cartridge assembly.

Example 16 is a tissue fixation system comprising a handle mechanism anda kit including a needle cartridge assembly and a tissue fixationapparatus coupled thereto. The handle mechanism includes a handle body,a tubular shaft, a plunger and a handle push rod. The handle body has aproximal end and a distal end and an internal cavity disposedtherebetween. The tubular shaft extends distally from the handle bodyand having a distal end. The plunger is slidably and rotatably coupledto the body and has a proximal end and a distal end, the proximal endpositioned external to and proximal to the handle body, the distal endpositioned within the internal cavity of the body. The handle push rodextends distally from the plunger and is slidably and rotatably disposedwithin the tubular shaft, the handle push rod including a distal matingfeature. The needle cartridge assembly includes an elongate needlecannula, a tubular sleeve, a cartridge push rod, and a resilient band.The needle cannula has an outer wall defining a proximal portion, anopposite sharpened distal tip having a distal opening, an internalchamber extending from the proximal portion through the distal opening,and a needle side opening through the outer wall. The tubular sleeve isfixedly disposed about a portion of the needle cannula having a proximalend and a distal end, the proximal end of the tubular sleeve configuredto mate with the distal end of the tubular shaft of the handle mechanismfor coupling the handle mechanism and the needle cartridge assembly. Thetubular sleeve further includes a sleeve side opening radially andaxially aligned with the needle side opening. The cartridge push rod isslidably and rotatably disposed within the internal chamber of theneedle cannula and includes a proximal mating feature configured toengage the distal mating feature of the handle push rod. The resilientband is disposed about disposed the tubular sleeve within the groove andover the side opening. The tissue fixation apparatus includes a firsttissue anchor, a second tissue anchor, and an adjustable suture assemblycoupling the first and second tissue anchors together. The adjustablesuture assembly includes an adjustable suture loop and a tension line,wherein the first and second tissue anchors are coupled to theadjustable suture loop, and wherein the tension line is operable toreduce a dimension of the adjustable suture loop between the first andsecond tissue anchors. The first tissue anchor is disposed within theinternal chamber of the needle cannula, the second tissue is disposedexternal to the internal chamber and within the needle and sleeve sideopenings, and the resilient band is disposed about the tubular sleeveover the second tissue anchor so as to urge the second tissue anchortoward the internal chamber through the needle and sleeve side openings.The cartridge push rod is positioned so as to prevent the second tissueanchor from entering the internal chamber. Upon coupling the tubularshaft of the handle mechanism and the tubular sleeve of the needlecartridge assembly together, and further wherein upon coupling themating features of the handle and needle push rods together, the plungerand the handle and cartridge push rods are configured to operate betweenat least one extended position and at least one retracted position. Inthe at least one extended position the cartridge push rod is located soas to eject the first tissue anchor from the internal chamber throughthe distal opening of the needle cannula while preventing the secondtissue anchor from entering the internal chamber. In the at least oneretracted position the cartridge push rod is positioned proximal to theside opening in the sleeve so as to allow the second tissue anchor to beurged into the internal chamber through the needle side opening by theresilient band.

In Example 17, the tissue fixation system of Example 16, wherein theproximal end of the tubular sleeve includes a proximal openingconfigured to receive the distal end of the tubular shaft of the handlemechanism so as to couple the handle mechanism to the needle cartridgeassembly.

In Example 18, the tissue fixation system of either of Examples 16 or17, wherein the distal end of the tubular shaft and the proximal openingof the tubular sleeve are sized to form an interference fit therebetweento couple the handle mechanism to the needle cartridge assembly.

In Example 19, the tissue fixation system of either of any of Examples16-18, wherein the distal end of the tubular shaft includes an alignmentpin extending radially outward therefrom, and wherein the proximal endof the tubular sleeve includes a notch sized to receive the alignmentpin to radially align the handle mechanism and the needle cartridgeassembly.

In Example 20, the tissue fixation system of any of Examples 16-19,wherein the tubular sleeve and the needle cannula each further includesa slot extending from the distal end thereof to the side openingthereof, the tubular sleeve slot being radially aligned with the slot inthe needle cannula, and wherein the slots of the tubular sleeve and theneedle cannula are sized to receive at least a portion of the adjustablesuture assembly of the tissue fixation apparatus.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are side elevation views of a tissue fixation systemincluding a delivery tool and a tissue fixation apparatus according toone embodiment of the present invention.

FIGS. 2A and 2B are, respectively, elevation and cross-sectionalelevation views of a handle mechanism portion of the delivery tool ofthe tissue fixation system of FIG. 1 according to one embodiment.

FIG. 3 is an exploded view of a needle cartridge portion of the deliverytool of the tissue fixation system of FIG. 1 according to oneembodiment.

FIG. 4 is a cross-sectional elevation views of the needle cartridgeportion of the delivery tool of the tissue fixation system of FIG. 1according to one embodiment.

FIGS. 5A-5F are elevation views of the tissue fixation system of FIG. 1shown in sequential stages of operation.

While the invention is amenable to various modifications and alternativeforms. specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION

FIG. 1A is a side elevation view of a tissue fixation system 100including a delivery tool 110 and a tissue fixation apparatus 115coupled thereto according to one embodiment of the present invention. Asshown in FIG. 1, the delivery tool 110 includes a handle mechanism 120and a needle cartridge assembly 125 coupled thereto. In variousembodiments, the handle mechanism 120 and the needle cartridge assembly125 are releasably coupled to one another to permit separation of theneedle cartridge assembly 125 after deployment of the tissue fixationapparatus 115. FIG. 1B is a side elevation view of the delivery tool 110showing the needle cartridge assembly 125 separated from the handlemechanism 120. This separable design advantageously allows, for example,multiple tissue fixation apparatuses 115 to be utilized where requiredfor a given medical procedure, while still allowing the handle mechanism120 of the delivery tool 110 to be reused if desired by the clinician.

As further shown, the tissue fixation apparatus 115 includes a sutureassembly 130, a portion of which (i.e., a tension line 132) is shown inFIG. 1A extending from the needle cartridge assembly 125 to a tab 134coupled to a portion of the handle mechanism 120. In the variousembodiments, the tissue fixation apparatus can take on variousconfigurations tailored for the particular medical procedure beingperformed. In various embodiments, the tissue fixation apparatusincludes a pair of tissue anchors (not shown in FIG. 1A) coupledtogether by the adjustable suture assembly 130 (e.g., via an adjustablesuture loop), which can be tightened by applying tension to the tensionline 132 after the tissue anchors are deployed into and secured withinthe target tissue.

Exemplary tissue fixation apparatuses that are contemplated within thescope of the various embodiments include, without limitation, thosedescribed in co-pending and commonly-assigned U.S. Patent ApplicationPublication No. 2007/0100348, the contents of which are incorporatedherein by reference in its entirety. As explained in further detailherein, in various embodiments, the tissue fixation apparatus 115 can besimplified from those disclosed in, for example, the aforementioned U.S.Patent Application Publication No. 2007/0100348 due to the design of thedelivery tool 110, which can eliminate the need for a separate sutureretention line coupled to the delivery tool for preventing unintendeddeployment of one of the tissue anchors as the tool is manipulated bythe clinician. In various embodiments, the tissue fixation system 100can be particularly useful for a variety of medical procedures,including without limitation, orthopedic procedures in the spine (e.g.,re-approximation of defects or tears of the annulus fibrosus), the knee(e.g., meniscal repair procedures), or the extremities. In variousembodiments, the tissue fixation system 100 can be useful for securingother medical devices (e.g., stimulation electrodes, catheters, and thelike) to body tissues.

As explained previously, and as can be seen in FIGS. 1A and 1B, thehandle mechanism 120 and the needle cartridge assembly 125 arereleasably coupled to one another to permit separation of the needlecartridge assembly 125 after deployment of the tissue fixation apparatus115. In such embodiments, multiple needle cartridge assemblies 125 canbe provided each pre-loaded with the tissue fixation apparatus 115. Upondeployment of a first tissue fixation apparatus 115, the needlecartridge assembly 125 can be detached from the handle mechanism 120, asshown in FIG. 1B, and a second needle cartridge assembly 125 with thetissue fixation apparatus 115 pre-loaded thereon can be attached to thehandle mechanism 120 (which can include releasably securing the tab 134to the handle mechanism 120 as shown in FIG. 1A). In variousembodiments, various kits including a range of needle cartridgeassemblies 125 and tissue fixation apparatuses 115 (e.g., with differenttissue anchor/suture constructs) can be provided to meet the particularneeds of the various stages of the medical procedure being performed.

FIGS. 2A and 2B are, respectively, elevation and cross-sectionalelevation views of the handle mechanism 120 of the delivery tool 110according to one embodiment. As shown in FIGS. 2A and 2B, the handlemechanism 120 includes, in the illustrated embodiment, a handle body140, a tubular shaft 145, a plunger 150, a handle push rod 155, a guidepin 158 and a spring 160. In the various embodiments, the handlemechanism 120 provides a means by which the clinician can manipulate andoperate the various features of the delivery tool 110, as will beexplained in further detail herein.

As further shown, the handle body 140 has a proximal end 165, anopposite distal end 170, an internal cavity 175, an external flange 180,and a post 184 defining a spring retaining channel 186. In oneembodiment, the external flange 180 is relatively flat and extends alonga longitudinal length of one side of the handle body 140, and provides ameans by which a clinician can grasp the handle mechanism 120 during useof the delivery tool 110. As further shown, the internal cavity 175extends generally longitudinally within the handle body 140, while thepost 184 and the spring retaining channel 186 extend generallyorthogonal to the longitudinal axis of the delivery tool 110 near theproximal end 165 of the body 140.

In the illustrated embodiment, the tubular shaft 145 includes a proximalend 190, which in the particular embodiment includes a collar 194, anopposite distal end 198, a longitudinal channel 200 and an alignment pin205. As shown, tubular shaft 145 is fixedly coupled to and extendsdistally from the distal end 170 of the handle body 140, and the collar194 is an enlarged diameter portion of the proximal end 190 and operatesto couple the tubular shaft 145 to the handle body 140. In variousembodiments, the collar 194 can be omitted, and the tubular shaft 145can be coupled to the handle body 140 by other means, or in someembodiments, can be integrally formed with the handle body 140.

As further shown in FIGS. 2A and 2B, the plunger 150 includes a proximalend 210, an opposite distal end 215, and an intermediate section 220therebetween defining an outer surface 224 of the plunger 150.Additionally, in the illustrated embodiment, the plunger 150 includes agroove arrangement 230 extending longitudinally and circumferentiallyalong the outer surface 224 of the intermediate section 220. Stilladditionally, the plunger 150 includes a control knob 235 at theproximal end 210, and a distal recess 240 at the distal end 215.

In the illustrated embodiment, the handle push rod 155 has a proximalend 245 and an opposite distal end 250. As further shown, the distal end250 includes a distal mating feature 255 including an inwardly extendingtooth 260 and a generally flat face 265 extending proximally withrespect to the tooth 260. In the illustrated embodiment, the majority ofthe handle push rod 155 (not including the distal mating feature 255)has a generally round cross-sectional profile, and can be solid ortubular. In other embodiments, other cross-sectional profiles (e.g.,rectangular, polygonal, elliptical, and the like) can be utilized forthis portion of the handle push rod 155.

As can be seen in FIGS. 2A and 2B, the proximal end 245 of the handlepush rod 155 is received within the distal recess 240 of the plunger 150and is fixedly coupled to the plunger 150 therein by any attachmentmeans. Additionally, the plunger 150 is partially disposed within theinternal cavity 175 of the handle body 140, with the proximal end 210and part of the intermediate section 220 of the plunger 140 disposedexternal and proximal to the handle body 140. Additionally, the proximalend 245 of the handle push rod 155 is disposed within the internalcavity 175, and from there the handle push rod 155 extends distallywithin the longitudinal channel 200 of the tubular shaft 145. As furthershown, the handle push rod 155 is sized such that its distal end 250,including the distal mating feature 255, can extend distally beyond thedistal end 198 of the tubular shaft 145.

In various embodiments, the plunger 150 and the handle push rod 155 areslidably and rotatably coupled to the handle body 140 and retainedpartially within the internal cavity 175 and the longitudinal channel200, as shown in FIGS. 2A and 2B. Thus, the plunger 150 and the handlepush rod 155 can be advanced distally and retracted proximally withrespect to the handle body 140 under clinician control, to effectdeployment of the tissue fixation apparatus 115 (see FIG. 1A). Asfurther shown, in the illustrated embodiment, the guide pin 158 isspring-biased toward the plunger 150 under the operation of the spring160, and extends partially into the groove arrangement 230 of theplunger 150. In this manner, the guide pin 158 operates to regulate anddelimit longitudinal and rotational movement of the plunger 150 and thehandle push rod 155 relative to the handle body 140. In addition, priorto deployment of the tissue fixation apparatus 115, in one embodiment,the tab 134 on the tension line 132 of the tissue fixation apparatus 115can be releasably coupled to the intermediate section 220 of the plunger150 between the knob 235 and the handle body 140 (see FIG. 1A). In thisarrangement, the tab 134 also operates to prevent unintended advancementof the plunger 150 relative to the handle body 140, thus requiring thetab 134 to be removed from the plunger 150 prior to deployment of thefirst tissue anchor of the fixation apparatus 115. In other embodiments,other or additional means can be employed to regulate the movement ofthe plunger 150 and the handle push rod 155 relative to the handle body140.

FIG. 3 is an exploded view of a needle cartridge assembly 125 of thedelivery tool 110, and FIG. 4 is a cross-sectional elevation views ofthe needle cartridge assembly 125 according to one embodiment. In FIG.4, tissue anchors 267, 268 of the fixation apparatus 115 are shown forillustration purposes. As shown, the needle cartridge assembly 125includes a needle cannula 270, a tubular sleeve 275, a cartridge pushrod 280 and a resilient band 285. As further shown, the needle cannula270 has an outer wall 290 that defines a proximal portion 295, anopposite sharpened distal tip 300 having a distal opening 304, and aninternal chamber 308. Additionally, in the illustrated embodiment, theneedle cannula 270 includes a needle side opening 310 and a slot 315. Asshown, both the needle side opening 310 and the slot 315 extend throughthe outer wall 290 to the internal chamber 308, with the slot 315extending from the distal opening 304 proximally to the side opening310.

As further shown, the tubular sleeve 275 includes an outer wall 318defining a proximal end 320 having a proximal opening 322, a proximalhead 324, and an opposite distal end 325. Additionally, in theillustrated embodiment, the tubular sleeve 275 includes a sleeve sideopening 330, a slot 335, a proximal alignment notch 340 and acircumferential recess 345. As shown, in one embodiment, the sleeve sideopening 330 and the slot 335 extend through the outer wall 318, with theslot 335 extending from the distal end 325 to the sleeve side opening330. Additionally, the proximal alignment notch 340 extendslongitudinally from the proximal end 320.

In the illustrated embodiment, the cartridge push rod 280 includes aproximal end 350 having a proximal mating feature 355, and an oppositedistal end 360. As further shown, the proximal mating feature 355includes an inwardly projecting tooth 365 and a generally flat face 370extending distally with respect to the tooth 365. In variousembodiments, the cartridge push rod 280 can be configured insubstantially the same or an identical manner as the handle push rod 155discussed previously.

As can be seen in FIGS. 3 and 4, when assembled, the proximal portion295 of the needle cannula 270 is disposed within and fixedly coupled tothe tubular sleeve 275, and is positioned such that the needle sideopening 310 is axially and radially aligned with the sleeve side opening330, and also such that the needle slot 315 is axially and radiallyaligned with the sleeve slot 335. The side openings 310, 335 are sizedto receive the tissue anchors 267, 268 therethrough with the tissueanchors 267, 268 generally aligned with the longitudinal axis of theneedle cannula 270 and tubular sleeve 275. Additionally, the slots 315,335 are sized to have widths smaller than the widths of the tissueanchors 267, 268 so as to prevent the tissue anchors 267, 268 fromexiting the chamber 308 of the needle cannula 270 during theirdeployment. In various embodiments, the slots 315, 335 operate toprovide a means by which a portion of the suture assembly of the tissuefixation apparatus 115 (see FIG. 1) can exit the internal chamber 308when one of the tissue anchors 267, 268, to which the suture assembly iscoupled, is disposed in the internal chamber 308.

As further shown, the distal end 360 of the needle push rod 280 isslidably disposed within the internal chamber 308 of the needle cannula270, and the proximal end 350 is disposed within the tubular sleeve 275within the proximal portion 295 thereof. As shown, the proximal matingfeature 355 has an outer dimension slightly smaller than the innerdimension of the tubular sleeve 275, thus allowing translation androtation of the cartridge push rod 280 while minimizing clearancebetween the mating feature 355 and the tubular sleeve 275 wall.

In various embodiments, the proximal head 324 and the proximal opening322 of the tubular sleeve 275 are sized and configured to receive thedistal end 198 of the tubular shaft 145 of the handle mechanism 120.Thus, to couple the handle mechanism 120 and the needle cartridgeassembly 125 together, the distal end 198 of the tubular shaft 145 isinserted into the proximal opening 322 of the tubular sleeve 275. In oneembodiment, the distal end 198 of the tubular shaft 145 and the proximalopening 322 of the tubular sleeve 275 are sized to form an interferencefit therebetween to couple the handle mechanism 120 to the needlecartridge assembly 125. In other embodiments, other means (e.g.,ball/socket joints, snap-fit connections, etc.) can be utilized toreleasably couple the handle mechanism 125 and the needle cartridgeassembly 125. The alignment pin 205 on the tubular shaft 145 can bereceived in the notch 340 in the tubular sleeve during the insertion ofthe distal end 198 into the tubular sleeve 275 to radially align thetubular shaft 145 and the tubular sleeve 275.

The mating features 255, 355 on the push rods 155, 280 are configured toengage one another upon coupling the handle mechanism 120 and the needlecartridge assembly 125. In the one embodiment, as the handle mechanism120 and the needle cartridge assembly 125 are joined together, the teeth260, 365 are configured to slide over one another to position the tooth260 on the handle push rod 155 is adjacent to the flat face 370 on thecartridge push rod 280, while the tooth 365 is positioned adjacent tothe flat face 265 of the handle push rod 155. This arrangement links thepush rods 155, 280 together such that push rods 155, 280 can be advanceddistally and retracted proximally together upon operator control of theplunger 150, with the teeth 260, 365 inhibiting unintended axialseparation of the push rods 155, 280. At the same time, the illustratedcoupling arrangement still allows the mating features 255, 355 todisengage one another when the needle cartridge assembly 125 isintentionally separated from the handle mechanism 125 by the clinician.In various other embodiments, other means (e.g., ball/socket joints,snap-fit connections, etc.) can be employed to releasably couple thepush rods 155, 280.

In one embodiment, the push rods 155, 280 can be automatically coupledtogether in the above manner upon insertion of the distal end 198 of thetubular shaft 145 into the proximal opening 322 of the tubular sleeve275. In other embodiments, the push rods 155, 280 can be coupledtogether as a subsequent assembly step (e.g., by advancing the plunger150 a predetermined distance after fully inserting the distal end 198 ofthe tubular shaft 145 into the proximal opening 322 of the tubularsleeve 275.

In various embodiments, where the tissue fixation apparatus 115 ispre-loaded onto the needle cartridge assembly 125, once the needlecartridge assembly 125 is coupled to the handle mechanism 120, the tab134 can be coupled to the intermediate section 220 of the plunger 150between the control knob 235 and the proximal end 165 of the handle body140, as shown in FIG. 1A.

FIG. 4 illustrates, in cross-section, the needle cartridge assembly 125with the tissue anchors 267, 268 loaded in a pre-deploymentconfiguration. As shown, in this configuration, the tissue anchor 267 ispositioned within the internal chamber 308 of the needle cannula 270,and the tissue anchor 268 is positioned within the side openings 310,330 of the needle cannula 270 and the tubular sleeve 275, respectively.The suture assembly 130 of the tissue fixation apparatus 115 (seeFIG. 1) is omitted for in FIG. 4, although those skilled in the art willreadily appreciate that the suture assembly 130 would be present in anassembled kit including the needle cartridge assembly 125 and thepre-loaded tissue fixation apparatus 130. As further shown, theresilient band 285 is positioned around the tubular sleeve 270 over theside opening 330, and thus over the tissue anchor 268, thus urging thetissue anchor 268 radially inward toward the chamber 308 of the needlecannula 270. However, as shown, in the pre-deployment configuration, thecartridge push rod 280 is positioned adjacent to the side openings 310,330 so as to prevent the tissue anchor 268 from being pushed into theinternal chamber 308 by the resilient band 285.

In various embodiments, the plunger 150 and the handle and cartridgepush rods 155, 280 are configured to operate between at least oneextended position and at least one retracted position relative to thehandle body 140 and the needle cannula 270 to effect loading, retention,and deployment of the tissue anchors 267, 268 into and from the chamber308 of the needle cannula 270. That is, the plunger 150 and the handleand cartridge push rods 155, 280 can be further extended distally fromthe position shown in FIG. 4, thereby ejecting the tissue anchor 267from the distal opening 304 of the needle cannula 270 while stillpreventing the tissue anchor 268 from entering the chamber 308. Theplunger 150 and the handle and cartridge push rods 155, 280 are furtherconfigured so as to be subsequently retractable to a retracted positionin which the distal end 360 of the cartridge push rod 280 is positionedproximal to the side openings 310, 330. In this position (not shown inFIG. 4), the tissue anchor 268 can be pushed into the internal chamber308 under the operation of a radial force exerted on the tissue anchor268 by the band 285. The plunger 150 and the handle and cartridge pushrods 155, 280 can then be again extended to an extended position toeject the tissue anchor 268 from the distal opening 304 of the needlecannula 270. Subsequently, the needle cartridge assembly 125 can bedisconnected from the handle mechanism 120 and discarded and, if theclinician desires or if necessary for the particular procedure, a secondneedle cartridge assembly 125 with a tissue fixation apparatus 115loaded thereon can be connected to the handle mechanism 120 and theabove steps repeated as required.

In various embodiments, the tissue fixation system 100 can be providedin a disassembled state, including the handle mechanism 120, and one ormore kits each including the needle cartridge assembly 125 pre-loadedwith the tissue fixation apparatus 115. In some embodiments, differentones of the needle cartridge assembly 125/tissue fixation apparatus 115kits can have different configurations (e.g., different sizes, lengths,anchor and/or suture configurations, etc.) so as to provide a wide rangeof flexibility and accommodate a range of clinical needs. In suchembodiments, the clinician can select the kit(s) having the particularneedle cartridge assembly 125 and/or tissue fixation apparatus 115configuration(s) best suited for the particular procedure beingperformed.

FIGS. 5A-5F are elevation views of the tissue fixation system 100 insequential stages of operation. FIG. 5A illustrates the handle mechanism120 and the needle cartridge assembly 125 prior to being connectedtogether. For ease of illustration, the suture assembly 130 of thetissue fixation apparatus 115 (see FIG. 1A) has been omitted from FIGS.5A-5F, although one skilled in the art will readily recognize thepresence of these elements in the various embodiments. The handlemechanism 120 and the needle cartridge assembly 125 are then joinedtogether, e.g., in the manner described above, for form the assembledtissue fixation system 100, as shown in FIG. 5B.

Subsequently, the distal tip 300 can be inserted into the target tissuelocation a desired depth, depending on the particular procedure beingperformed. For example, when used in an orthopedic procedure such as adisc annulus re-approximation or a meniscal repair procedure, the distaltip 300 can be inserted into or through the outer surface of the annulusor meniscus proximate the defect to be re-approximated. As anotherexample, when used to secure an implant to soft tissue, the distal tipcan be inserted into the soft tissue adjacent to the implant at a firstlocation. Once the distal tip 300 is inserted as desired, the plunger150 can be advance distally relative to the handle body 140, thusejecting the first tissue anchor 267 from the needle cannula 270 andinto the target tissue, as shown in FIG. 5C.

Next, the distal tip 300 can be removed from the target tissue at thefirst location and relocated to a second location selected as requiredfor the particular procedure (e.g., either on the other side of thedefect in the annulus or knee meniscus, or on the other side of theimplant to be secured). The distal tip 300 can then be inserted into thetissue at this second location. Subsequently, the plunger 150, andconsequently, push rods 155, 280 can be retracted proximally so that thedistal end 360 of the push rod 280 is positioned proximal to the sideopenings 310, 330, as shown in FIG. 5D, and the corresponding “Detail.”With the push rods 155, 280 so positioned, the tissue anchor 268 isloaded into the internal chamber 308 under the action of the band 285,as shown. In one embodiment, the plunger 150, and in particular, thegroove arrangement 230, is configured such that it must be rotated to afree position to allow for retraction of the plunger 150 and the pushrods 155, 280, although in other embodiments other plunger movementregulation techniques are utilized.

Next, the plunger 150 and the push rods 155, 280 can again be extendeddistally relative to the handle body 140, thus ejecting the secondtissue anchor 268 from the needle cannula 270 and into the targettissue, as shown in FIG. 5E. The distal tip 300 can then be removed fromthe tissue. As shown in FIG. 5F, the handle mechanism 120 and the needlecartridge assembly 125 can be disconnected from one another. If desired,a second needle cartridge assembly 125 and tissue fixation apparatus 115can then be connected to the same handle mechanism 120 for deployment asdictated by the particular procedure being performed.

The materials used in the delivery tool 110 can include any number ofbiocompatible materials having suitable mechanical properties. Exemplarymaterials can include, but are not limited to: metals, such as stainlesssteels, nickel, titanium alloy, and titanium; plastics, such aspolytetrafluoroethylene (PTFE), polypropylene, polyether etherketone(PEEK™), polyethylene, polyethylene teraphthalate (PET) andpolyurethane, acrylic, polycarbonate, engineering plastics; and/orcomposites. In short, any suitable materials, whether now known or laterdeveloped, can be utilized to construct the implant delivery tool 110within the scope of the present invention.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. For example, while the embodiments described above refer toparticular features, the scope of this invention also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present invention is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

What is claimed as new and desired to be protected under Letters Patentof the United States is:
 1. A device for deploying tissue anchors, thedevice comprising: a handle defining an internal cavity; a tubularassembly extending distally from the handle and comprising a groove anda first side opening; a needle cannula comprising an outer wall, aproximal portion disposed within the tubular assembly, an oppositesharpened distal tip having a distal opening, an internal chamberextending from the proximal portion through the distal opening, and asecond side opening through the outer wall; a plunger assembly slidablycoupled to the handle and comprising a proximal end positioned externalto and proximal to the handle and a push rod assembly, wherein portionsof the push rod assembly are slidably disposed within handle, thetubular assembly, and the needle cannula; and a resilient band disposedabout the tubular assembly within the groove and over the first sideopening; wherein the device is configured and arranged so that, prior todeployment, a first tissue anchor can be disposed within the internalchamber of the needle cannula and a second tissue anchor can be disposedexternal to the internal chamber within the first side opening in thetubular assembly, and wherein the plunger assembly is positioned toprevent the second tissue anchor from entering the internal chamberwhile the resilient band operates to urge the second tissue anchortoward the internal chamber.
 2. The device of claim 1, furthercomprising the first tissue anchor disposed within the internal chamberof the needle cannula; and the second tissue anchor disposed external tothe internal chamber within the first side opening in the tubularassembly.
 3. The device of claim 2, further comprising an adjustablesuture assembly coupled to the first anchor and the second anchor. 4.The device of claim 3, wherein the device is configured and arranged forthe adjustable suture assembly to be releasably coupleable to thehandle.
 5. The device of claim 1, wherein the plunger assembly comprisesa plunger slidably coupled to the handle and comprising the proximal endof the handle and a distal end positioned within the internal cavity ofthe handle.
 6. The device of claim 5, wherein the push rod assemblycomprises a first push rod extending distally from the plunger andslidably disposed within the tubular assembly, the first push rodcomprising a distal mating feature; and a second push rod slidablydisposed within the internal chamber of the needle cannula andcomprising a proximal mating feature configured to engage the distalmating feature of the first push rod.
 7. The device of claim 6, whereinthe distal mating feature of the first push rod is releasably coupleableto the proximal mating feature of the second push rod.
 8. The device ofclaim 1, wherein the tubular assembly comprises a tubular shaftextending distally from the handle and comprising a distal end; and atubular sleeve disposed about a portion of the needle cannula andcomprising a proximal end, the groove, and the first side opening, theproximal end of the tubular sleeve configured to mate with the distalend of the tubular shaft.
 9. The device of claim 8, wherein the distalend of the tubular shaft is configured and arranged to releasably matewith the proximal end of the tubular sleeve.
 10. The device of claim 1,wherein the plunger assembly is configured and arranged to operatebetween an extended position and a retracted position, wherein in theextended position the push rod assembly extends to eject the firsttissue anchor from the internal chamber through the distal opening ofthe needle cannula while preventing the second tissue anchor fromentering the internal chamber, wherein in the retracted position thepush rod assembly is retracted to allow the second tissue anchor to beurged into the internal chamber through the first side opening and thesecond side opening by the resilient band.
 11. The device of claim 1,wherein the plunger assembly comprises an intermediate section includingan outer surface and a groove arrangement therein, wherein the handlecomprises a guide pin extending radially inward, the guide pin beingspring biased toward the plunger assembly so as to extend partiallywithin the groove arrangement to regulate longitudinal movement of theplunger assembly relative to the handle.
 12. A method of using thedevice of claim 2, the method comprising: inserting the sharpened distaltip of the needle cannula into patient tissue at a first location;advancing the push rod assembly to eject the first tissue anchor fromthe needle cannula into the patient tissue at the first location;withdrawing the needle cannula from the first location; inserting thesharpened distal tip into the patient tissue at a second location;retracting the push rod assembly with respect to the needle cannula toallow the second tissue anchor to be pushed into the interior chamber ofthe needle cannula under the operation of the resilient band disposedabout the needle cannula and the second tissue anchor; advancing thepush rod assembly to eject the second tissue anchor from the needlecannula into the patient tissue at the second location; and withdrawingthe needle cannula from the patient tissue.
 13. The method of claim 12,wherein the device further comprises an adjustable suture assemblycoupled to the first anchor and the second anchor, the method furthercomprising tightening the adjustable suture assembly.
 14. A device fordeploying a tissue fixation apparatus, the device comprising: a handledefining an internal cavity; a tubular shaft extending distally from thehandle; a plunger slidably coupled to the handle and comprising aproximal end positioned external to the handle and a distal endpositioned within the internal cavity of the handle; a handle push rodextending from the distal end of the plunger and slidably disposedwithin the tubular shaft; a needle cannula comprising an outer wall, aproximal portion, an opposite sharpened distal tip having a distalopening, an internal chamber extending from the proximal portion throughthe distal opening, and a needle side opening through the outer wall; atubular sleeve disposed about a portion of the needle cannula andreleasably mateable with the tubular shaft, the tubular sleevecomprising a groove and a sleeve side opening; a cartridge push rodslidably disposed within the internal chamber of the needle cannula andreleasably mateable with the handle push rod; and a resilient banddisposed about the tubular sleeve within the groove and over the sleeveside opening; wherein the device is configured and arranged to receive afirst tissue anchor within the internal chamber of the needle cannulaand a second tissue anchor within the side sleeve opening and externalto the internal chamber of the needle cannula.
 15. The device of claim14, further comprising the first tissue anchor disposed within theinternal chamber of the needle cannula; and the second tissue anchordisposed external to the internal chamber within the sleeve side openingin the tubular sleeve.
 16. The device of claim 15, further comprising anadjustable suture assembly coupled to the first anchor and the secondanchor.
 17. The device of claim 16, wherein the device is configured andarranged for the adjustable suture assembly to be releasably coupleableto the handle.
 18. The device of claim 14, wherein the plunger and thehandle push rod and the cartridge push rod are configured to operatebetween an extended position and a retracted position, wherein in theextended position the cartridge push rod is configured and arranged toeject the first tissue anchor from the internal chamber through thedistal opening of the needle cannula while preventing the second tissueanchor from entering the internal chamber, wherein in the retractedposition the cartridge push rod is positioned proximal to the sleeveside opening so as to allow the second tissue anchor to be urged intothe internal chamber through the needle side opening by the resilientband.
 19. A method of using the device of claim 15, the methodcomprising: inserting the sharpened distal tip of the needle cannulainto patient tissue at a first location; advancing the cartridge pushrod assembly within the needle cannula to eject the first tissue anchorfrom the needle cannula into the patient tissue at the first location;withdrawing the needle cannula from the first location; inserting thesharpened distal tip into the patient tissue at a second location;retracting the cartridge push rod with respect to the needle cannula toallow the second tissue anchor to be pushed into the interior chamber ofthe needle cannula under the operation of the resilient band disposedabout the needle cannula and the second tissue anchor; advancing thecartridge push rod within the needle cannula to eject the second tissueanchor from the needle cannula into the patient tissue at the secondlocation; and withdrawing the needle cannula from the patient tissue.20. The method of claim 19, wherein the device further comprises anadjustable suture assembly coupled to the first anchor and the secondanchor, the method further comprising tightening the adjustable sutureassembly.